Quality by Design

Missouri City, TX (Oct. 3)-The US District Court for the Western District of Texas denied the Department of Justice?s motion to alter its Aug. 30 decision that the US Food and Drug Administration does not have the ability to regulate drug compounding.

The Bulk Pharmaceuticals Task Force (BPTF), an affiliate organization of the Synthetic Organic Chemical Manufacturers Association (SOCMA, Washington, DC) submitted a citizen petition to the US Food and Drug Administration (Washington, DC) requesting the agency to increase inspections of drug manufacturing facilities located outside of the United States.

Companies must create a risk-based framework for developing and manufacturing drugs, and acquire the scientific knowledge and technological skills to create more complex products.

CDER is reorganizing staffs and developing new policies to encourage industry adoption of quality production systems.

OTC Eye-Drop Maker Signs Consent Decree

CDER 2005 Product Approval Totals Proposed CDER Reorganization

US District Court Rejects FDA Suit to Block Device Manufacturer

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The author describes strategies for analytical method development that are helpful in achieving quality by design and efficiency.